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Trial of Extended Release Bupivacaine for Pain Relief After Surgery

NCT02574520 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 399

Last updated 2021-07-13

Study results available
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Summary

This is a research study of SABER® -Bupivacaine, an experimental medication designed to reduce pain for up to 3 days after surgery. Given once by the surgeon at the end of surgery, SABER® - Bupivacaine delivers a locally-acting pain reliever directly to the surgical wound.

The purpose of this study is to measure how well it works in reducing pain after laparoscopic cholecystectomy (surgery to remove the gall bladder) and to investigate the safety of SABER®-Bupivacaine (its side effects).

Conditions

  • Post Operative Pain

Interventions

DRUG

SABER-Bupivacaine (Part 1)

5 ml once at end of surgery

DRUG

SABER-Bupivacaine (Part 2)

5 ml once at end of surgery

DRUG

Saline Placebo

5 ml once at end of surgery

DRUG

Bupivacaine HCl

0.5%, 15 ml, once at end of surgery

Sponsors & Collaborators

  • Durect

    lead INDUSTRY

Principal Investigators

  • Dave Ellis, MD · Durect

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-06-30
Completion
2017-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02574520 on ClinicalTrials.gov